Effect of Early Enteral Nutrition on Postoperative Recovery of Ovarian Cancer Patients

Advanced Epithelial Ovarian Cancer Clinical Trial

Official title:

Clinical Study on the Effect of Early Enteral Nutrition Implemented by Placing Nasojejunal Tube During Ovarian Cancer Surgery on Patients' Postoperative Recovery and Prognosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06236958
• Other study ID #: 2023-SR-499
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: January 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Luo Chengyan, Doctor
• Phone: 13914751661
• Email: betteryuan66[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a single-center, unblinded, prospective observational study, and the objective is to compare the effects of enteral nutrition via nasojejunal tube and parenteral nutrition via vein on patients' early recovery and prognosis who undergo tumor cytoreduction for ovarian cancer.

Description:

Ovarian cancer is the most lethal disease among gynecological malignancies, and its treatment is a comprehensive one mainly based on surgery. The perioperative nutritional status of patients affects their postoperative recovery, subsequent adjuvant therapy, and their prognosis. Hence, nutritional support therapy should be initiated for such patients in the early postoperative period to prevent further malnutrition. Conventional postoperative nutritional support therapy is performed through parenteral nutrition via vein, while the application of enteral nutrition via the nasojejunal tube in the postoperative period of ovarian cancer has not been reported in the literature. Therefore, in this study, the investigators took advantage of the characteristics of long surgical incisions and the wide surgical scope of ovarian cancer to investigate the effects of placing a nasojejunal tube during the operation and early enteral nutrition on postoperative recovery and prognosis in patients with advanced ovarian cancer, with the aim of accelerating the postoperative recovery of the patients, decreasing the incidence of postoperative complications, supplementing adjuvant chemotherapy in time, improving the survival outcome of the patients with advanced ovarian cancer, and providing gynecologists with a basis for enteral nutritional support therapy via nasojejunal tube after ovarian cancer surgery. In this study, the patients placed with a nasojejunal tube during the operation and enteral nutrition after the operation were included in the observation group, and the patients without a nasojejunal tube and parenteral nutrition after the operation were included in the control group. And the two groups were compared in terms of the indicators of postoperative recovery, the incidence of complications within the 30 days after operation, the cost of hospitalization, hospital stay, the interval between the operation and the first chemotherapy, the survival outcome, etc. The data involved in the study came from patient files, hospital databases, and long-term follow-up results.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• (1) The age is more than 18 years old and not more than 75 years old; (2) Ovarian cancer patients who are clearly diagnosed as epithelial ovarian cancer by pathological examination, whose tumors involve organs other than the pelvis as determined by preoperative imaging and intraoperative visual judgment, and who are at FIGO stage III or IV, and who undergo tumor cytoreductive surgery; (3) Patients without contraindication to nasoenteric tube placement and enteral nutrition; (4) Patients and their families were informed of the significance of the early use of enteral nutrition, precautions, adverse reactions, etc., before the operation, and they gave informed consent to this study and signed the informed consent; (5) Patients who received treatment in our hospital with complete clinical data.

Exclusion Criteria:

• (1) Patients with intestinal obstruction, severe intestinal infection, severe diarrhea, and acute abdomen right before surgery; (2) Patients with esophagogastric fundal varices and active gastrointestinal bleeding right before surgery; (3) Patients who undergo surgery to simultaneously resect the intestinal canal in the area more than 15cm distal to the ligament of Traitz; (4) Patients with severe cardiac, hepatic, and renal failure; (5) Patients with severe rhinitis, nasal mucous membrane damage, bleeding; (6) Patients with other malignant tumors combined within 3 months before surgery; (7) Metastatic ovarian cancer; (8) Those with missing clinical information; (9) Those with known hypersensitivity to enteral nutrition preparations.

Related Conditions & MeSH terms

• Advanced Epithelial Ovarian Cancer
• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms

Intervention

Device:
• Transnasal jejunal tube
A naso-jejunal tube was placed in the operation, which is placed 15 cm below Traitz's ligament. A short-peptide enteral nutrient solution was heated by an enteral nutrient pump and infused into the patients within 24 hours after the operation. Before and at the end of the infusion, physiological saline was given to flush the tube, and at the end of the infusion, the catheter was closed to prevent liquid reflux and blockage of the tube. The catheter should be clamped shut at the end of the infusion. During the infusion period, the patient's gastrointestinal tolerance was dynamically evaluated. According to the results of a regular review of nutritional indicators, including hemoglobin, albumin, electrolytes, liver and kidney function, etc., increase the amount of enteral nutrients; remove the nasojejunal tube when the patient has no abdominal distension after exhaustion and feeding; and change to feeding through the mouth.

Other:
• Transvenous access
A uniform drip of nutritional solution was started 24 hours postoperatively. Configuration of nutritional solution: glucose and medium/long-chain fat emulsion as the main energy substances to provide calories, calculated at 30 ~ 35 kcal/(kg-d), glucose-fat ratio is 6:4, pancreatic glucose ratio for those without a history of diabetes mellitus is 1:6 ~ 8, and for diabetic patients depending on the level of glucose, pancreatic glucose ratio is 1:3 ~ 4, and then assisted with subcutaneous injections of insulin to control glucose, if necessary. Pay attention to the total amount of rehydration fluid, electrolytes, vitamins, and trace elements supplemented. Mix the nutrient solution evenly in the laminar flow clean table and infuse it through the route at 2500~3000 ml/d; the infusion time is 8~12 h/d. After exhaustion, start to eat through the mouth.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Luo Chengyan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin	To record the patient's hemoglobin on postoperative days 7 and 14 according to routine blood results	postoperative days 7, and 14
Primary	Intervals from surgery to the initiation of postoperative exhaustion and defecation	To record intervals from surgery to the initiation of postoperative exhaustion and defecation according to the medical record	one month after surgery
Primary	The hospital stay after surgery and intervals from surgery to initiation of postoperative chemotherapy	To record the hospital stay after surgery and intervals from surgery to initiation of postoperative chemotherapy according to the medical record	one month after surgery
Primary	The cost of hospitalization of peri operation	To record the cost of a patient's hospitalization of peri operation according to the medical record	one month after surgery
Primary	Incidence of complications postoperative complications	To record the incidence of complications patient's postoperative complications for 30 days according to medical records, including: fever, intestinal obstruction, intestinal fistula, thrombosis, pulmonary embolism, poor incision healing, etc.	one month after surgery
Primary	Quality of life scores	To assess patients' quality of life scores on postoperative day 3 according to functional assessment of cancer therapy-ovary cancer (FACT-O) vision 4.0, with a minimum value of 0 and a maximum value of 156. The higher scores are, the better quality of postoperative survival is.	postoperative days 3
Primary	Serum sodium and potassium	To record the patient's serum sodium and potassium on postoperative days 7 and 14 according to biochemical results.	postoperative days 7, and 14
Primary	Abnormal liver function	To record the number of patients with abnormal liver function within 30 days postoperatively according to biochemical results. Abnormal liver function was defined as serum alanine aminotransferase and/or aspartate aminotransferase higher than 2.5 times the upper limit of normal values.	postoperative days 7, and 14
Primary	Abnormal renal function	To record the number of patients with abnormal renal function within 30 days postoperatively according to biochemical results. Abnormal renal function was defined as serum creatinine and/or urea higher than 2.5 times the upper limit of normal values.	postoperative days 7, and 14
Primary	Serum albumin	To record the patient's serum albumin on postoperative days 7 and 14 according to biochemical results.	postoperative days 7, and 14
Secondary	Survival outcomes	Survival outcomes at 3 years postoperatively, including progression, recurrence, death, and survival	three years after surgery
Secondary	Incidence of complications related to nasojejunal tubes	To record the incidence of complications related to tube placement in patients in the nasojejunal group according to medical records	one month after surgery